Duns Number:022721133
Device Description: Oxygen Tubing Swivel Connector For low pressure, not to exceed 689 mbar (10 psi).
Catalog Number
M1225-0
Brand Name
N/A
Version/Model Number
M1225-0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
TUBING, PRESSURE AND ACCESSORIES
Public Device Record Key
bc7823b0-e79e-4b36-be18-c58cff68c7f2
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
December 16, 2016
Package DI Number
10607411889865
Quantity per Package
25
Contains DI Package
00607411889868
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |